NCT05124015|Completed
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Sponsor study identifier
observational
33
1 country
1
Study Start
November 10, 2019
Actual (reported)Primary Completion
April 10, 2021
Actual (reported)Study Completion
January 1, 2022
Actual (reported)The primary aim of this study was to evaluate exercise capacity, respiratory muscle strength, pulmonary function, dyspnea and physical activity levels in pediatric PAH patients and compare them with healthy controls. The secondary aim of the study was; To investigate the relationship of dyspnea with exercise capacity, respiratory muscle strength, respiratory functions, physical activity and blood count parameters in pediatric PAH patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 10, 2019
Actual (reported)April 10, 2021
Actual (reported)November 15, 2021
Actual (reported)November 17, 2021
Actual (reported)January 1, 2022
Actual (reported)Exercise capacity
Functional exercise capacity was evaluated using the 6- Minute Walk Test. 6- Minute Walk Test will be applied according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
First Day
Respiratory muscle strength
First Day
Pulmonary function (Forced vital capacity (FVC))
First Day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
First day
Pulmonary function (FEV1 / FVC)
First day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
First Day
Exercise capacity using six minute walk test, respiratory muscle strength using mouth pressure device, pulmonary function using spirometry, dyspnea using Modified Borg scale physical activity using multi-sensor activity monitor.
Exercise capacity using six minute walk test, respiratory muscle strength using mouth pressure device, pulmonary function using spirometry, dyspnea using Modified Borg scale physical activity using multi-sensor activity monitor.
13 patients with PAH and 15 healthy individuals were included in the study.
Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Ankara, Çankaya, 06580, Turkey (Türkiye)
Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
McGoon M, Gutterman D, Steen V, Barst R, McCrory DC, Fortin TA, Loyd JE; American College of Chest Physicians. Screening, early detection, and diagnosis of pulmonary arterial hypertension: ACCP evidence-based clinical practice guidelines. Chest. 2004 Jul;126(1 Suppl):14S-34S. doi: 10.1378/chest.126.1_suppl.14S.
Ece Baytok, Pt. MSc
Gazi University, Faculty of Health Sciences, Department of Cardiopulmonary Physical Therapy and Rehabilitation
Gülşah Barğı, PhD. Pt.
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Betül Yoleri, Pt. MSc
Gazi University, Faculty of Health Sciences, Department of Cardiopulmonary Physical Therapy and Rehabilitation
Fatma İncedere, Dr
Gazi University
33 participants (actual enrollment reported by the registry).
First Submitted
November 15, 2021
First Posted
November 17, 2021
Study Start
November 10, 2019
Actual (reported)Prevalence of Musculoskeletal Pain and Its Impact on Quality of Life and Functional Exercise Capacity in Patients With Pulmonary Arterial Hypertension
Contact the study team to confirm eligibility.
Douwes JM, Hegeman AK, van der Krieke MB, Roofthooft MT, Hillege HL, Berger RM. Six-minute walking distance and decrease in oxygen saturation during the six-minute walk test in pediatric pulmonary arterial hypertension. Int J Cardiol. 2016 Jan 1;202:34-9. doi: 10.1016/j.ijcard.2015.08.155. Epub 2015 Aug 28.
Cappelleri JC, Hwang LJ, Mardekian J, Mychaskiw MA. Assessment of measurement properties of peak VO(2) in children with pulmonary arterial hypertension. BMC Pulm Med. 2012 Sep 10;12:54. doi: 10.1186/1471-2466-12-54.
Smith G, Reyes JT, Russell JL, Humpl T. Safety of maximal cardiopulmonary exercise testing in pediatric patients with pulmonary hypertension. Chest. 2009 May;135(5):1209-1214. doi: 10.1378/chest.08-1658. Epub 2008 Dec 31.
Serdar Kula, Prof.Dr.
Gazi University
Fatma Sedef Tunaoğlu, Prof.Dr.
Gazi University
Meral Boşnak Güçlü, Prof. Dr.
Gazi University, Faculty of Health Sciences, Department of Cardiopulmonary Physical Therapy and Rehabilitation
Primary Completion
April 10, 2021
Actual (reported)Study Completion
January 1, 2022
Actual (reported)Last Updated
March 25, 2025
Record last verified: 2021-11
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